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Mauna Kea Technologies Announces Positive Results from Mayo Clinic Sponsored Prospective Multi-Center Trial in Lung Transplant Patients

Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (OTCQX: MKEAY) (Euronext:
MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary
probe-based confocal laser endomicroscopy (pCLE) platform, today
announced the publication of a prospective multicenter study
(ClinicalTrials.gov Identifier: NCT01033201) that demonstrates the
potential of Cellvizio to aid in the diagnosis of acute cellular
rejection in lung transplant patients. The article, entitled “Diagnosis
of Acute Cellular Rejection Using Probe-Based Confocal Laser
Endomicroscopy in Lung Transplant Recipients: a Prospective,
Multi-Center Trial,” was published in Transplantation (2018, DOI: 10.1097/TP.0000000000002306)
and can be downloaded here: https://journals.lww.com/transplantjournal/Abstract/onlinefirst/Diagnosis_of_Acute_Cellular_Rejection_Using.96508.aspx.

“The lung has the highest rate of acute rejection of any transplanted
organ,” said Cesar Keller, M.D., Lung Transplant Program, Mayo Clinic,
Jacksonville, Florida and first author of the study. “However, the
current standard of care, transbronchial biopsy, requires multiple
samples to be obtained per biopsy and carries a high risk of serious
adverse events including pneumothorax and/or pulmonary bleeding.
Considering the relatively frequent need to monitor these patients for
acute rejection, better and less invasive methods to assess acute
rejection would significantly improve patient care and outcomes.”

Acute cellular rejection (ACR) in lung transplant recipients is
diagnosed by identifying perivascular cellularity (PVC) from alveolar
tissue typically obtained via invasive transbronchial biopsies. This
study compared in vivo real-time histological imaging using
Cellvizio for the identification of alveolar, vascular, and cellular
microstructures of lung transplants to transbronchial biopsies. The
prospective, multi-center study enrolled 24 patients who had undergone a
lung transplant within the prior 12 months and who were scheduled for
diagnostic biopsies. The study showed that pCLE identification of PVC is
a feasible and reproducible criterion for assessment of acute cellular
rejection in vivo. The PVC criterion exhibited a perfect
sensitivity for the ACR diagnosis for a pCLE-trained pneumologist. After
training, the inter-observer agreement among four pneumologists to
recognize this feature was significant (Fleiss Kappa of 0.77). The
authors concluded that “optical biopsy obtained with pCLE identifies
micro-vascular structures with and without perivascular cellularity,
which correlates with standard histological diagnosis of acute cellular
rejection.”

“Cellvizio is the only probe-based Confocal Laser Endomicroscopy system
available to physicians for clinical use in pulmonology,” said Sacha
Loiseau, Ph.D., CEO and co-founder of Mauna Kea Technologies. “This
study adds further validation to Cellvizio’s unique capabilities to not
only identify microscopic cellular and vascular structures within the
tissues inside the human body in real time, but to also generate
actionable results with significant impact on patient outcomes.”

About Mauna Kea TechnologiesMauna Kea Technologies is a
global medical device company focused on eliminating uncertainties
related to the diagnosis and treatment of cancer and other diseases
thanks to real time in vivo microscopic visualization. The
Company’s flagship product, Cellvizio, has received clearance to sell a
wide range of applications in more than 40 countries, including the
United States, Europe, Japan, China, South Korea, Canada, Brazil and
Mexico. For more information on Mauna Kea Technologies, visit www.maunakeatech.com

DisclaimerThis press release contains forward-looking
statements concerning Mauna Kea Technologies and its activities. Such
forward looking statements are based on assumptions that Mauna Kea
Technologies considers to be reasonable. However, there can be no
assurance that the anticipated events contained in such forward-looking
statements will occur. Forward- looking statements are subject to
numerous risks and uncertainties including the risks set forth in the
registration document of Mauna Kea Technologies registered by the French
Financial Markets Authority (Autorité des marchés financiers (AMF)) on
April 27, 2018 under number R.18-0429 and available on the Company’s
website (www.maunakeatech.com),
and to the development of economic situation, financial markets, and the
markets in which Mauna Kea Technologies operates. The forward-looking
statements contained in this release are also subject to risks unknown
to Mauna Kea Technologies or that Mauna Kea Technologies does not
consider material at this time. The realization of all or part of these
risks could lead to actual results, financial conditions, performances
or achievements by Mauna Kea Technologies that differ significantly from
the results, financial conditions, performances or achievements
expressed in such forward-looking statements. This press release and the
information it contains do not constitute an offer to sell or to
subscribe for, or a solicitation of an order to purchase or subscribe
for, Mauna Kea Technologies shares in any country.

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